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Exenatide Prolonged-Release Suspension for Injection in Combination with Oral Antidiabetic Therapy for the Treatment of Type 2 Diabetes (TA248)

on the 26 March 2012

Technology Appraisal Guidance No. 248

Source: National Institute for Health and Care Excellence

1. Guidance

1.1 Prolonged-release exenatide in triple therapy regimens (that is, in combination with metformin and a sulphonylurea, or metformin and a thiazolidinedione) is recommended as a treatment option for people with type 2 diabetes as described in 'Type 2 diabetes: the management of type 2 diabetes' (NICE clinical guideline 87); that is, when control of blood glucose remains or becomes inadequate (HbA1c ≥ 7.5% [59 mmol/mol] or other higher level agreed with the individual), and the person has:

a body mass index (BMI) ≥ 35 kg/m2 in those of European family origin (with appropriate adjustment for other ethnic groups) and specific psychological or medical problems associated with high body weight or

a BMI < 35 kg/m2, and therapy with insulin would have significant occupational implications or weight loss would benefit other significant obesity-related comorbidities.

1.2 Treatment with prolonged-release exenatide in a triple therapy regimen should only be continued as described in 'Type 2 diabetes: the management of type 2 diabetes' (NICE clinical guideline 87); that is, if a beneficial metabolic response has been shown (defined as a reduction of at least 1 percentage point in HbA1c [11 mmol/mol] and a weight loss of at least 3% of initial body weight at 6 months).

1.3 Prolonged-release exenatide in dual therapy regimens (that is, in combination with metformin or a sulphonylurea) is recommended as a treatment option for people with type 2 diabetes, as described in 'Liraglutide for the treatment of type 2 diabetes mellitus' (NICE technology appraisal 203); that is, only if:

the person is intolerant of either metformin or a sulphonylurea, or a treatment with metformin or a sulphonylurea is contraindicated, and

the person is intolerant of thiazolidinediones and dipeptidyl peptidase-4 (DPP-4) inhibitors, or a treatment with thiazolidinediones and DPP-4 inhibitors is contraindicated.

1.4 Treatment with prolonged-release exenatide in a dual therapy regimen should only be continued as described in 'Liraglutide for the treatment of type 2 diabetes mellitus' (NICE technology appraisal guidance 203); that is, if a beneficial metabolic response has been shown (defined as a reduction of at least 1 percentage point in HbA1c [11 mmol/mol] at 6 months).

The guidance shown above constitutes Section 1 of the full document. A copy of the full document and a summary of the evidence is available on the Internet at http://guidance.nice.org.uk/TA248

This guidance represents the view of the Institute which was arrived at after careful consideration of the available evidence. Health professionals are expected to fully take it into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.